IN THE NEWS THIS WEEK
April 12, 2016

CDRH in Transition:
Preparing for a New Enforcement System

The looming realignment of CDRH's programs and retooling of inspection procedures have raised many questions among device makers trying to prepare for future inspections.

Currently, device makers are used to seeing one "generic" investigator at their inspections and they are used to investigators following the approach set out in the FDA's Investigations Manual and Quality Systems Inspection Technique.

But that's all about to change, creating a "perfect storm" that will leave device makers drowning in unfamiliar waters. Now is the time to make preparations to weather that storm, and CDRH in Transition: Preparing for a New Enforcement System is the place to start. In this report, noted industry expert John Avellanet gives his well-informed perspective on where CDRH enforcement is headed and what adjustments devicemakers will need to survive.

CDRH in Transition:  Preparing for a New Enforcement System  outlines how - and when - CDRH plans to update its programs in the coming years and how device makers should respond. Think of it as your to-do list for the next 18 months!


pdf version will be available April 22, 2016
News From the Hill
Coats Amendment to Continue
Transportation of Lithium Batteries for Use in Medical Devices Passes Senate
WASHINGTON, DC -  Senator Dan Coats (R-Ind.) today praised the passage of his amendment to the  Federal Aviation Administration Reauthorization Act that would grant an exemption to the proposed ban on transporting lithium batteries via passenger aircraft. The amendment was offered by Coats and Senator Bill Nelson (D-Fla.).

"Many Hoosiers rely on lithium batteries for their critical medical devices, such as pacemakers, heart pumps and wearable defibrillators," said Coats. "It is important that patients can obtain the batteries they need to operate their life-saving medical devices." 

The Coats amendment would allow lithium batteries to be transported on passenger aircraft if the batteries are used as a part of a medical device. The
  amendment passed the Senate unanimously.
________________________________________
OTHER NEWS
The Senate Health Committee last Wednesday advanced a final round of medical innovation bills as lawmakers intensify their push for a deal on funding medical research. 

The panel advanced five bills aimed at speeding up Food and Drug Administration (FDA) approval of new drugs and devices. The measures will be combined with several other bills to become the Senate's version of the House-passed 21st Century Cures Act. 
IMDMC MEMBER NEWS
The MES Solution
by John Dzelme, Global Chief Operating Officer 
Seabrook Technology Group 

The ever-changing landscape of the Life Sciences sector creates numerous challenges for medical device manufacturers. Increasing cost pressures, diminishing geographical barriers and the onset of Industry 4.0 means that achieving operational excellence is no longer just a strategic initiative; it is becoming a  survival tactic.

The cost of compliance and product traceability continues to mount as regulations grow increasingly stricter and counterfeiting becomes more innovative. These combined challenges are eroding profitability to unprecedented levels. In addition, the growing popularity of consumer medical devices has led to intensified demand for more sophisticated products, requiring ever more complex manufacturing and engineering processes.

The combined pressures not only threaten profitability, but also impact the ability of organizations to remain agile, innovative and competitive. In order to remain on the cutting edge, it is imperative that the medical device manufacturing industry changes its current approach to Manufacturing Operations Management (MOM).

The advanced technologies in Manufacturing Execution Systems (MES)/MOM will enable organizations to systematically enforce compliance, enhance product quality, eliminate waste and promote continuous improvement. MES is the solution to the current challenges being experienced by medical device manufacturers and will also ensure they achieve and sustain a state of operational excellence .

Some key ways MES benefits medical device manufacturers include:
* Elimination of paper-based manufacturing processes which is error-prone and inhibits growth
  * Managing of greater product complexity and output throughout the manufacturing process 
* Agility, flexibility and continuous growth 
* Full traceability and product genealogy

Typical cost savings achieved through an MES being implemented are significant, including:
* Overall cost of compliance 
* Savings in paper, printing and archiving
* Wasted effort in handling and inspecting data entries in paper documents 
* ROI can be achieved on average of 12-18 months

MES solutions, coupled with appropriate operations strategies, can ultimately provide the right products with the right level of quality in the right quantity, at a price customers are willing to pay. 
 
For more information see www.seabrookglobal.com
Quote of the Week: John Wooden    

"Whatever you do in life, surround yourself with smart people who'll argue with you."     
In Case You Missed This News...
New York
Venture Summit 
Where Innovation Meets Capital

July 20th & 21st, 2016 | Crowne Plaza | New York City 

Come meet, interact and network with more than 500 VCs, Corporate VCs, angel investors, investment bankers and CEOs of early stage and emerging growth companies at the prestigious  New York Venture Summit being held on July 20th - 21st , 2016 at the Crowne Plaza in New York City.

Whether you're a startup seeking capital and exposure, or an investor seeking new deals, The New York Venture Summit presented by youngStartup Ventures - is the event of the year you won't want to miss.

This exclusive summit will feature a distinguished line up of more than 50 Investors on interactive panels; presentations by more than 50 cutting edge companies seeking funding, and high-level networking opportunities.

To Register now and receive the special 10% discount provided by our partner, IHIF, as well as take advantage of the "Early Bird" discount rate, use the link and enter discount code "IHIFVIP": 
In addition to providing access to leading Investors, the conference will feature more than 50 pre-screened early stage companies seeking capital, and hardcore networking. 

Call for TOP INNOVATORS!
Get Noticed > Get Funded > Grow Faster

A select group of more than 50 Top Innovators from the Technology, Life Sciences/Healthcare, CleanTech and Edtech sectors will be chosen to present their breakthrough investment opportunities to an exclusive audience of Venture Capitalists, Private Investors, Investment Bankers, Corporate Investors, and Strategic Partners.

Apply to Present / Nominate a company:
For more information or to be considered for one of the Top Innovator slots click here: http://bit.ly/1oyNbNe 

Seed Pitchfest:
If you are a seed stage company seeking angel funding of less than $1M (and have raised less than $300,000) click here to apply for our Seed stage track sponsored by the National Science Foundation.

REGISTER NOW and Save!!

FEES: "Early bird" registration Savings Available for a limited time! Use Promotional code "IHIFVIP" and receive an extra 10% off.
Entrepreneurs: Regular: $395 | At the Door: $790
Investors: Regular: $495 | At the Door: $990)
Service Providers: Regular: $695 | At the Door: $1,390)
Featured IMDMC Associate Member Company
Ortho Accelerator Targets Innovators



The chief executive officer of the state's orthopedics initiative says a new accelerator will support the "lifeblood" of the industry. Sheryl Conley, President and CEO of OrthoWorx, says the AcceLinx Medical Device Business Accelerator from Warsaw-based OrthoWorx will provide entrepreneurs with in-house and industry partner expertise, assist with access to capital and offer working space. Conley says concepts in the orthopedics industry can take more than six years to hit the market. 

Conley says "companies in our region account for leading global market shares and approximately $17B in annual revenue. One of OrthoWorx's fundamental purposes, in addition to the work we've done in talkent development and talent attraction, is to foster innovation in our state to enhance the environment for our industry and support the communities that rely on it." She adds that "industry and service providers in the region offer everything an entrepreneur would need to advance a business plan...and the concentration of suppliers and access to human capital for advice and guidance is unmatched."

As members of IMDMC, your companies are important to us. If you have company news you would like IMDMC to share, please send me an email. Both Corporate and Associate Members are encouraged to submit new hires, company
announcements and profiles,or op-ed's. Please limit your copy to 500 words or less. 

We look forward to highlighting all of our companies!

Sincerely,

Kathy Heuer
Executive Director
IMDMC
In This Issue
Quick Links
IMDMC  State Advocacy
IMDMC Upcoming Events
LAST CHANCE TO REGISTER!!
Reg 101 & 102 Workshop on April 21 & May 19

Sponsor by
Med Institute

Day 1 Agenda 4/21/16
  • FDA Overview
  • Regulatory Intelligence
  • Clinical Trials/IDE's
  • Pathways to Market 510K Requirements
  • Pathways to Market PMA Requirements
  • Other Submissions & Special Issues
  • Pre-Market QSR
  • Labeling, Advertising & Promotion
  • Current FDA Initiatives
  • Panel Discussion "Linking the Pieces" and Q&A
Day 2 Agenda 5/19/16
  • Interactions with FDA
  • QSR
  • Reimbursement
  • Complaint handling/Medical Device Reporting
  • Sales & Marketing: Regulatory Aspects
  • Recalls and Field Corrections
  • Inspsections
  • Enforcement
  • Other Liability Mechanisms

When
Thursday April 21, 2016 from 8:00 AM to 5:00 PM and 
May 19, 2016 from 8:00 AM to 5:00 PM 

Where  
THE MONTAGE
8580 Allison Pointe Boulevard
Indianapolis, IN 46250
  

IMDMC Annual Conference
IMDMC Annual Conference to be  
October 27, 2016

Senator Dan Coats to be featured Speaker

Exhibit Booth Room will again be available


Other Educational Opportunities



What's New at IHIF
Click Here


Interested in Joining IMDMC? 
Indiana Medical Device Manufacturers Council | 260-609-2802 | imdmc@imdmc.org | http://www.imdmc.org
PO Box 441385
Indianapolis, IN 46244